Lead, Clinical Pharmacology & MIDD Strategy

Zai Lab (US) LLC; South San Francisco (CA); On-site; USD 198,000 - 257,000; Full time

Job summary

Zai Lab Limited in the United States seeks an Associate Director of Clinical Pharmacology & MIDD to lead quantitative pharmacology efforts across development programs. You will shape PK/PD, population PK, PBPK, and model-based decision making, coordinating with Regulatory Affairs, Translational Sciences, Biostatistics, and external partners.

The role emphasizes strategy development, study design, and regulatory interactions to support global development and lifecycle management of small and

Qualifications

• BS in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Systems Pharmacology, Biomedical Engineering, or a related discipline with 10 years of experience in clinical pharmacology, pharmacometrics, MIDD, or related quantitative sciences supporting drug development; or equivalent combination of higher education, training and experience.
• PhD with at least 7 years’ related experience.
• Demonstrated experience developing and executing integrated Clinical Pharmacology and MIDD strategies across multiple stages of drug development, including regulatory submissions and health authority interactions.

Responsibilities

• Lead the Clinical Pharmacology and MIDD strategy from early development through registration and lifecycle management.
• Develop and execute integrated Clinical Pharmacology and Modeling & Simulation plans with clear quantitative objectives.
• Lead design, execution, analysis, and interpretation of clinical pharmacology studies and translational PK/PD modelling.
• Ensure regulatory quality and compliance of analyses and deliverables.
• Represent Clinical Pharmacology in cross-functional teams and with health authorities.

Skills

Clinical pharmacology

MIDD (model-informed Drug Development)

PK/PD modelling

Population PK

Regulatory interactions

Education

BS in Clinical Pharmacology or related

PhD (preferred)

Tools

NONMEM

Monolix

Simcyp

GastroPlus

R

Job description

Zai Lab Limited in the United States seeks an Associate Director of Clinical Pharmacology & MIDD to lead quantitative pharmacology efforts across development programs. You will shape PK/PD, population PK, PBPK, and model-based decision making, coordinating with Regulatory Affairs, Translational Sciences, Biostatistics, and external partners.

The role emphasizes strategy development, study design, and regulatory interactions to support global development and lifecycle management of small and